This invention relates to the field of medical devices, and more particularly to a method of forming a thin-walled member for an intralumenal medical device.
In the design of intralumenal catheters, the progression of improvements has been to decrease the catheter profile, while accommodating the conflicting characteristics of catheter strength and flexibility. These catheter characteristics significantly effect catheter maneuverability and, therefore, the ability to effectively position the catheter at a desired location within a patient. The catheter profile and flexibility are a function of the wall thickness of the various catheter components. While the catheter shaft must have sufficient strength, and therefore sufficient wall thickness, to provide torque transmission and kink resistance, sleeves disposed about the catheter balloon or shaft are generally made very thin. Such sleeves are used to strengthen, protect, or otherwise modify the surface of the catheter balloon or shaft. For example, a sleeve may be provided at the junction of two catheter shaft sections to strengthen the joint. Also, balloon catheters used for stent delivery are typically provided with a protective sleeve between the balloon and the stent mounted thereon. The wall thickness of such tubular sleeves should be very thin to minimize the effects on catheter profile and flexibility.
Polymeric tubular catheter components are typically formed by extrusion, although they may be made by a variety of methods depending on the material used and the desired characteristics of the component. For example, in free extrusion, melted polymeric material passes through an extrusion die over a mandrel. Where a multilayered article is desired, the layers may be co-extruded, or a second layer extruded over an existing polymeric tube. The wall thickness of an extruded tube is a function of the annular gap between the die and the mandrel, and post extrusion processing such as draw-down of the polymeric material. Draw-down is the ratio of the die diameter to the final diameter of the extruded article, and is therefore a measure of the thinning of the extruded article as it exits the extruder.
While extrusion is a preferred technique for forming polymeric tubular catheter components, a thin-walled continuous as-extruded tube has heretofore been unavailable. A variety of technical problems are encountered which prevent the extrusion of a tube having a wall thickness of about 0.003 inch (0.0076 cm) or less, that is suitable for use as a catheter component. For example, such thin-walled tubes loose shape retention during movement through the solidification phase and the take-up system of the extruder. Because of the small annular gap between the die and mandrel used to produce the thin-walled article, the extruded article is prone to melt fracture, i.e. the formation of a rough and irregular surface on the article. Moreover, a tube produced by extrusion using a conventionally sized die and mandrel annular gap cannot be processed into a thin-walled catheter component by drawing-down the tube, because the degree to which wall thickness can be thus reduced is limited. For example, during draw-down to produce a thin-walled tube, the tube wall may tear, or intralumenal air pressure used to maintain the inner diameter dimensions of the tube will produce ballooning of the tube wall.
Therefore, what has been needed is a method of producing a thin-walled tubular catheter component by extrusion. The present invention satisfies these and other needs.
The invention is directed to a method of forming a thin-walled member for a medical device, and the member produced thereby. The method of the invention generally comprises co-extruding a two layered polymeric member, such as a polymeric tube, and removing and discarding one of the layers, with the remaining layer forming the thin-walled member. The thin-walled member extruded using the method of the invention is suitable for use as a component of an intralumenal catheter.
One aspect of the invention is a thin-walled polymeric member formed by extrusion, and preferably having a single wall thickness of not greater than about 0.003 inch (0.0076 cm). In the method of the invention, the thin-walled member is formed as a thin-walled first polymer layer co-extruded with a removable second polymer layer. The first polymer layer may be co-extruded adjacent either an inner surface or an outer surface of the second polymer layer. The thickness of the thin-walled member of the invention is a function the flow rate of the polymer melt supplied to the co-extrusion die and the draw-down of the extrudate. Controlling the wall thickness of a thin-walled tube is difficult when the tube is extruded as a single layered tube. In contrast, the co-extrusion method of the invention allows the dimensions of the first polymer layer to be sized accurately and controllably. The method of the invention may be used to extrude thin-walled members of a variety of configurations including tubular, oblong, square, and elliptically shaped members, and members having complex shapes such as multilumen members. Additionally, another aspect of the invention is directed to a tubular member, such as a metallic hypotube, having a thin-walled polymer layer extruded thereon. Hypotubes are typically used as a stiff proximal shaft section in a catheter, and details of catheter designs having hypotubes may be found in U.S. Pat. Nos. 4,998,923 and 5,480,383, incorporated by reference herein in their entireties.
Because the method of the invention involves co-extruding a removable second polymer layer along with the thin-walled first polymer layer, a conventional annular gap between the extruder die and mandrel may be used. A conventional annular gap used in extrusion of tubular catheter components is about 0.01 to about 0.015 in (0.025 to about 0.04 cm). Despite the large size of a conventionally sized extruder annular gap, conventional extruder tooling can be used in the method of the invention to produce a thin-walled tubular member having a wall thickness of about 0.003 inch or less because most of the space is filled by the removable second polymer layer.
The removable second polymer layer is typically formed as the outer of the two co-extruded layers in order to facilitate its removal from the thin-walled first polymer layer. However, the removable layer may, alternatively, be on an inner surface of the thin-walled layer. Depending on the nature of the polymers which form the thin-walled and removable layers, the separation of the layers may be by a variety of methods. A presently preferred method involves dissolving the removable layer in a solvent that does not dissolve the thin-walled layer. Alternatively, the removable layer may be physically separated from the thin-walled layer, as by peeling or cutting away of the removable layer.
The method of the invention allows a thin-walled member to be formed by extrusion. The extrudate has excellent shape retention and structural integrity necessary for withstanding the solidification and take-up system of the extruder, due to the removable second polymer layer co-extruded with the thin-walled first polymer layer. The temporarily combined co-extruded layers provide for easy handling and improved kink resistance in the extrudate during post production processing. Moreover, because the method of the invention can be used to extrude a thin-walled tube using a conventionally sized die and mandrel combination, melt fracture in the extrudate is avoided, particularly on the outer surface of the inner layer.
A benefit of the method of the invention is that the thin-walled member can be made extremely thin, i.e. not greater than about 0.003 inch, and with a very accurately maintained thickness along its length. This helps minimize the outer diameter of an intralumenal device having the thin-walled member. Thus, when used for example as a sleeve over the junction of two joined catheter shaft sections or over a balloon, the thin-walled tubular member of the invention provides a low-profiled, smooth sleeve with superior fit over the catheter shaft or balloon.
These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.